Astellas Highlights Data Advancing Cancer Care and Innovation for Patients with Hard-to-Treat Cancers at ESMO 2026

–  PADCEV™ (enfortumab vedotin) plus pembrolizumab data highlight durable survival benefit in advanced bladder cancer –

– VYLOY™ (zolbetuximab) research reinforces the role of CLDN18.2 in shaping gastric cancer treatment decisions –

TOKYO, Oct. 6, 2026 /PRNewswire/ — Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, “Astellas”) today announced that 21 abstracts from its oncology portfolio will be presented at the European Society for Medical Oncology Congress 2026 (ESMO 2026), taking place October 23–27 in Madrid, Spain. The presentations span prostate, urothelial, gastric/gastroesophageal junction (GEJ), lung and pancreatic cancers, reflecting Astellas’ commitment to advancing standards of care and pursuing new scientific approaches designed for cancers where significant unmet need remains.

Astellas stands on the forefront of healthcare change to turn innovative science into value for patients.(PRNewsFoto/Astellas Pharma Inc.)

Moitreyee Chatterjee-Kishore, Ph.D., MBA, Executive Vice President and Head of Oncology Development, Astellas:

“Standards of care do not change by accident. The data being presented at ESMO 2026 demonstrate how a deep understanding of disease biology and differentiated modalities is helping advance care for patients with bladder, gastric, and prostate cancers, including through approaches such as PADCEV™ (enfortumab vedotin) plus pembrolizumab, VYLOY™ (zolbetuximab), and XTANDI™ (enzalutamide). We are building upon this knowledge to develop the next generation of therapeutic options for cancers where unmet needs remain and look forward to engaging in discussions about this work at the congress.”

Highlights from Astellas’ ESMO 2026 presentations include:

  • Enfortumab vedotin plus pembrolizumab presentations include the longest follow-up reported to date in locally advanced or metastatic urothelial cancer, along with analyses across patient subgroups and treatment settings. Additional presentations include trials in progress exploring bladder preservation in muscle-invasive bladder cancer.
  • Zolbetuximab presentations examine CLDN18.2 assessment, patient identification and real-world use, reinforcing the growing body of evidence supporting CLDN18.2-guided treatment decisions in gastric and GEJ cancers.
  • Pipeline presentations feature trials-in-progress across Astellas’ investigational programs, including Phase 3 trials of setidegrasib in KRAS G12D-mutated pancreatic and non-small cell lung cancers, a Phase 1 trial of ASP5834 in KRAS-mutated or amplified solid tumors, and a Phase 1b/2 trial of ASP546C in CLDN18.2-expressing solid tumors. Together, these investigational studies illustrate Astellas’ continued investment in advancing new approaches aimed at overcoming challenges that have limited progress in hard-to-treat cancers.

Additional details on Astellas’ presentations at ESMO 2026 are included below.

Presentation Title

Lead Author

Presentation Details

Enfortumab vedotin



EV-103 DE/Cohort A and Cohort K Final

Analysis:
 Enfortumab vedotin with or

without pembrolizumab as first-line

treatment for cisplatin (cis)-ineligible locally

advanced or metastatic urothelial

carcinoma: long-term follow-up analysis

from EV-103 cohorts DE/A and K

J. P. Maroto Rey

Type: Rapid oral

Abstract number: 4740RO

Date/time: Saturday, October 24,

10:15-11:45

EV-302 Comorbidities (DCO3): 

Enfortumab vedotin plus pembrolizumab for

previously untreated locally advanced or

metastatic urothelial carcinoma: updated

exploratory analysis of EV-302 in older

patients and those with comorbidities

S. S. Sridhar

Type: Poster

Abstract number: 4761P

Date/time: Friday, October 23,

15:15-16:00

EV-302 Clinical Subgroups (DCO3): 

Enfortumab vedotin + pembrolizumab in

previously untreated locally advanced or

metastatic urothelial cancer: exploratory

analyses based on disease-related

characteristics from EV-302

J. Bedke

Type: Poster

Abstract number: 4760P

Date/time: Friday, October 23,

15:15-16:00

EVOLVE 3: Real-world treatment patterns

in patients with locally advanced and

metastatic urothelial cancer in France

F. Joly

Type: ePoster

EV-303/KN-905 ITT3: Perioperative

pembrolizumab or enfortumab vedotin plus

pembro in participants with muscle-invasive

bladder cancer who are cisplatin-ineligible:

ad hoc analysis from KEYNOTE-905

A. Ullén

Type: Proffered paper session

Abstract number: 4733O

Date/time: Friday, October 23,

13:30-15:00

EV-304/KN-B15 ctDNA: ctDNA analysis of

the phase 3 KEYNOTE-B15 trial:

neoadjuvant and adjuvant enfortumab

vedotin + pembrolizumab for participants

with muscle-invasive bladder cancer who

are eligible for cisplatin

J. Chatzkel

Type: Proffered paper session

Abstract number: 4734O

Date/time: Friday, October 23,

13:30-15:00

EV-304/KN-B15 ePRO: Health-related

quality of life with neoadjuvant and adjuvant

enfortumab vedotin plus pembrolizumab in

participants (pts) with muscle-invasive

bladder cancer eligible for cisplatin in the

phase 3 KEYNOTE-B15 study

A. Gómez De Liaño

Type: Rapid oral

Abstract number: 4738RO

Date/time: Saturday, October 24,

10:15-11:45

EV-209 TiP: EV-209: an open-label, single-arm,

phase 2 study of enfortumab vedotin plus

pembrolizumab for bladder preservation in

patients with muscle-invasive bladder cancer

eligible for radical cystectomy

Thomas Powles

Type: Poster

Abstract number: 4769TiP

Date/time: Friday, October 23,

15:15-16:00

EV-309 TiP: EV-309: an open-label,

randomized, phase 3 study of enfortumab

vedotin plus pembrolizumab for bladder

preservation in patients with muscle-invasive

bladder cancer

Matthew D. Galsky

Type: Poster

Abstract number: 4770TiP

Date/time: Friday, October 23,

15:15-16:00

Enzalutamide



Adelpi REALIZE: High-risk biochemically

recurrent (hrBCR) hormone sensitive

prostate cancer (PC): European real-world

(RW) evidence on risk stratification, PSMA

PET use, and physician practices

A. Merseburger

Type: ePoster

Abstract number: 2063eP

Date/time: N/A

AMNOG NMA in mHSPC: Network meta-analysis

(NMA) on the safety of androgen receptor pathway

inhibitors (ARPIs) in patients with metastatic

hormone-sensitive prostate cancer (mHSPC) from

German AMNOG dossiers

C. Ohlmann

Type: Poster

Abstract number: 2295P

Date/time: Friday, October 23,

15:15-16:00

CASPER: Outcomes of enzalutamide

(ENZ) and apalutamide (APA) in metastatic

hormone-sensitive prostate cancer

(mHSPC): a Canadian real-world (RW) study

B. Shayegan

Type: ePoster

Abstract number: 2329eP

Date/time: N/A

ARCHES/ARANOTE indirect safety

comparison
: Indirect safety comparison of

enzalutamide (ENZA) and darolutamide

(DARO) with androgen-deprivation therapy

(ADT) in metastatic hormone-sensitive

prostate cancer (mHSPC)

S. Shariat

Type: Poster

Abstract number: 2294P

Date/time: Friday, October 23,

15:15-16:00

EMBARK deep PSA response: Deep

prostate-specific antigen (PSA) response

by prior definitive treatment (tx) in patients

(pts) with high-risk biochemically recurrent

prostate cancer (hrBCR): EMBARK post

hoc analysis

S. Freedland

Type: Poster

Abstract number: 2293P

Date/time: Friday, October 23,

15:15-16:00

Zolbetuximab



SPOTLIGHT ctDNA: ctDNA Assessment in

Patients with CLDN18.2+, HER2−, Locally

Advanced Unresectable or Metastatic (la/m)

Gastric or Gastroesophageal Junction

Adenocarcinoma (G/GEJ a) in SPOTLIGHT

K. Shitara

Type: Poster

Abstract number: 2882P

Date/time: Sunday, October 25,

12:00-12:45

Canadian PSP: Real-World Use of

Zolbetuximab Plus Chemotherapy (CTx) in

Patients With CLDN18.2+, HER2−, Locally

Advanced (LA) Unresectable or Metastatic

Gastric or Gastroesophageal Junction

Cancer (mGC/GEJC)  in a Canadian

Patient Support Program (PSP)

H. Karachiwala

Type: Poster

Abstract number: 2941P

Date/time: Sunday, October 25,

12:00-12:45

Pipeline



Phase 3 PDAC TiP: A Phase 3, double-blind,

randomized trial of setidegrasib + mFOLFIRINOX

or NALIRIFOX as first-line treatment for patients

with metastatic pancreatic ductal adenocarcinoma

(PDAC) harboring KRAS G12D mutations: Trial in

progress

T. Macarulla

Type: Poster

Abstract number: 3190TiP

Date/time: Sunday, October 25,

12:00-12:45

Phase 3 NSCLC TiP: Phase 3,

randomized, open-label trial of setidegrasib

vs docetaxel in patients with KRAS G12D-mutated

locally advanced or metastatic non-small cell lung

cancer (NSCLC) that progressed on or after

platinum-based chemotherapy and checkpoint inhibitor

(CPI) therapy: Trial in progress

F. Skoulidis

Type: ePoster

Abstract number: 2871eTiP

Date/time: N/A

Phase 1b/2 TiP: Phase 1b/2 study of

ASP546C, a Claudin 18.2-targeting

antibody-drug conjugate with a

topoisomerase 1 inhibitor payload, in

patients with Claudin 18.2-expressing

unresectable locally advanced or metastatic

solid tumors

T. Macarulla

Type: ePoster

Abstract number: 1133eTiP

Date/time: N/A

FiH TiP: A phase 1 study of ASP5834 in

patients with locally advanced or metastatic

solid tumors with Kirsten rat sarcoma viral

oncogene homologue (KRAS) mutations or

amplifications

S. Sen

Type: ePoster

Abstract number: 1145eTiP

Date/time: N/A

Combination clinical data for mss CRC:

A phase 1/2 study of ASP1570 for locally

advanced/metastatic microsatellite-stable

(MSS) colorectal cancer (CRC)

V. Boni

Type: ePoster

Abstract number: 1090eP

Date/time:
N/A

About Astellas

Astellas is a global life sciences company committed to turning innovative science into value for patients. We provide transformative therapies in disease areas that include oncology, ophthalmology, urology, immunology and women’s health. Through our research and development programs, we are pioneering new healthcare solutions for diseases with high unmet medical need. Learn more at www.astellas.com.

About PADCEV and the Pfizer, Astellas and MSD Collaboration

Seagen and Astellas previously entered a clinical collaboration agreement with MSD to evaluate the combination of Seagen’s and Astellas’ PADCEVTM (enfortumab vedotin) and MSD’s KEYTRUDA® (pembrolizumab) in patients with urothelial cancer. Pfizer Inc. successfully completed its acquisition of Seagen on December 14, 2023. KEYTRUDA is a registered trademark of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Rahway, NJ, USA (known as MSD outside of the United States and Canada).

About XTANDI and the Pfizer/Astellas Collaboration

In October 2009, Medivation, Inc., which is now part of Pfizer (NYSE:PFE), and Astellas (TSE: 4503) entered into a commercial agreement to jointly develop and commercialize XTANDI® (enzalutamide) in the United States, while Astellas has responsibility for manufacturing and all additional regulatory filings globally, as well as commercializing the product outside the United States. Pfizer receives alliance revenues as a share of U.S. profits and receives royalties on sales outside the U.S.

Cautionary Notes

In this press release, statements made with respect to current plans, estimates, strategies and beliefs and other statements that are not historical facts are forward-looking statements about the future performance of Astellas. These statements are based on management’s current assumptions and beliefs in light of the information currently available to it and involve known and unknown risks and uncertainties. A number of factors could cause actual results to differ materially from those discussed in the forward-looking statements. Such factors include, but are not limited to: (i) changes in general economic conditions, and in laws and regulations, relating to pharmaceutical markets, (ii) currency exchange rate fluctuations, (iii) delays in new product launches, (iv) the inability of Astellas to market existing and new products effectively, (v) the inability of Astellas to continue to effectively research and develop products accepted by customers in highly competitive markets, and (vi) infringements of Astellas’ intellectual property rights by third parties. Information about pharmaceutical products (including products currently in development) which is included in this press release is not intended to constitute an advertisement or medical advice.

Cision View original content to download multimedia:https://www.prnewswire.com/news-releases/astellas-highlights-data-advancing-cancer-care-and-innovation-for-patients-with-hard-to-treat-cancers-at-esmo-2026-302900206.html

SOURCE Astellas Pharma Inc.

Disclaimer: The above press release comes to you under an arrangement with PR Newswire. Bubblear.com takes no editorial responsibility for the same.

PR Newswire

PR Newswire is a distributor of press releases headquartered in New York City.